The company is one of the global leaders in the Medical Devices industry. They manufacture, market and distribute high quality and high-tech products and operate in more than 90 countries worldwide.

The Supplier Quality Engineer (SQE) has an integral role within the QA / RA department and manage the supplier quality program, ensuring that suppliers deliver quality parts, materials, and services. This position must drive incoming quality by evaluating new and existing suppliers, and resolving supplier issues to closure in a timely manner. SQE will provide supplier qualifications, product issue resolution, driving supplier corrective actions, and maintain the approved supplier list. Audits Suppliers per compliance with regulatory and corporate requirements. The SQE implements and maintains a comprehensive supplier management system to ensure that incoming products comply with regulatory and corporate requirements. As part of the organization, you are committed to the highest standards of patient safety, quality and integrity.

General Functions

• Develop positive relationships and work closely with Global Supplier Management to manage and implement supplier changes, New Product Introductions, and transfers;
• Qualification of Suppliers (Strategic Alliance Partners and Service / Consumable suppliers) through robust qualification processes;
• Developing, negotiating and concluding quality assurance agreements with Strategic Alliance Partners and subcontractors;
• Conduct supplier on-site and desk top audits as a lead auditor and coordinates other assessments/surveys and support Global Audit group and internal audit group;
• Identifies risks to products and processes that trace to deficient quality systems, uncontrolled critical parameters, changing regulatory requirements, and changing technical requirements;
• Monitoring of Supplier Quality by collects and analyses quality metrics from various quality systems and lead the Supplier Review Board and provides recommendations based on trends;
• Collaborates with Sourcing to track ongoing supplier quality performance and work with suppliers on quality issues;
• Follow-up on quality issues with Strategic Alliance Partners (including SCARS); Manages and monitors implementation and effectiveness of corrective actions related to non-conformities;
• MDR Label and IFU reviews of Strategic Alliance Partners products;
• Collect and administrate storage and distribution requirements. Eg on temperature or humidity;
• Maintains accuracy and completeness of all Supplier Files and the Approved Supplier List (ASL);
• Coordinates Supplier Change Requests;
• Maintain Supplier Quality Procedures within the QMS and following-up regulatory and corporate requirements;
• Act as contact for Strategic Alliance Partners documents and follow-up on GTS blocks of Strategic Alliance Partners products and requesting regulatory and quality documents;
• Acts as a resource to work groups and project teams relative to quality and regulatory issues;
• Supports and/or leads projects using continuous improvement tools and methodologies.

We are looking for

The companies team members share the singular purpose of working to restore mobility and improve the quality of life for patients around the world. They are looking for team members who would like to make a difference in people's lives. They are always searching for talented, dedicated and motivated people with a range of skills, experiences and backgrounds to join their team. Are you next to join them?

Profile of candidate

Education      

• Bachelor‘s Degree in the field of Mechanical, Industrial Engineering or logistics or equivalent experience;
• Quality Management training with Diploma examination;
• Lead Auditor training with Diploma examination (ISO 13485 preferred).

Professional experience

• Minimum of 2 – 4 years’ experience in a Quality Role, preferred as Supplier Quality Engineer within manufacturing or distribution (preferably medical devices or pharmaceuticals);
• Broad knowledge of regulatory requirements (MDR / FDA / ISO 13485 / GMP etc.);
• Experience in interpreting and applying regulations and standards, auditing to these standards and processes good verbal and written communications abilities;
• Understanding of all engineering fields and internal processes to be audited;
• Industry know how in medical devices and/or related fields;
• Experienced in project management;
• Familiar with a variety of office software packages including MS Word, Power Point, Visio, Excel and SAP etc.

Languages

• Excellent verbal and written communication skills in English (and preferably Dutch).

Personal skills and competencies

• Committed to Quality and Continues Improvement mindset;
• Flexible and hands-on attitude;
• Strong communication skills and organizationally and cultural sensitive, persisted and analytical;
• Team player and able to work well with diverse groups of people and be able to function independently of direct supervision;
• Ability to think critically, anticipating/ recognizing and managing risk;
• Organizationally and cultural sensitive, persisted and analytical;
• Persuasive, decisive and proactive.

Travel requirements

• Possibly up to 5%.

What they offer

This is your chance to push the boundaries of innovation and make a valued contribution to helping people around the world find renewed vitality starts here! They offer you a responsible job in an exciting, dynamic and growing environment, to make it even better they also:

• support you with thorough training and continuous development;
• offer an attractive compensation package.

 Interested?

Please upload your resume via the apply button or call for further inquiries to Nobesse Recruitment; Monique Nobel tel. +31 (0)6 41 576 904.